Label: PRISMA PROTECT SPF30- homosalate, octocrylene, octisalate, and avobenzone lotion
- NDC Code(s): 68479-851-01, 68479-851-02, 68479-851-04
- Packager: Dermalogica, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 11, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun care measures, (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- Apply liberally 30 minutes before sun exposure
- Reapply at least every two hours
- Use a water-resistant sunscreen if swimming or sweating
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and take other sun protection measures including:
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- Limit time in the sun, especially from 10 a.m. – 2 p.m.
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- Wear long-sleeve shirts, pants, hats and sunglasses
- Do not use on infants under 6 months old
- Other information
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Inactive ingredients
Water/Aqua/Eau, Butylene Glycol, Silica, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Butyloctyl Salicylate, Polyglyceryl-2 Distearate, VP/Eicosene Copolymer, Chlorella Vulgaris Extract, Zingiber Officinale (Ginger) Root Oil, Camellia Sinensis Leaf Extract, Tocopheryl acetate, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Arachidyl Alcohol, Dimethicone Crosspolymer, Behenyl Alcohol, Caprylic/Capric Triglyceride, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arachidyl Glucoside, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Citric Acid, Sodium Citrate, Caprylyl Glycol, Polyvinyl Alcohol, 1,2-Hexanediol, Pentylene Glycol, Propanediol, Saccharide Isomerate, Bisabolol, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate, Lactic Acid/Glycolic Acid Copolymer, Heptapeptide-15 Palmitate, Limonene.
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- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
PRISMA PROTECT SPF30
homosalate, octocrylene, octisalate, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-851 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 10 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 10 g in 100 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Silicon Dioxide (UNII: ETJ7Z6XBU4) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Dimethicone (UNII: 92RU3N3Y1O) Glycerin (UNII: PDC6A3C0OX) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Polyglyceryl-2 Distearate (UNII: 1XAX7BOH4W) Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Glyceryl Monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) Pentylene Glycol (UNII: 50C1307PZG) Propanediol (UNII: 5965N8W85T) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Saccharide Isomerate (UNII: W8K377W98I) Docosanol (UNII: 9G1OE216XY) Caprylyl Glycol (UNII: 00YIU5438U) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Xanthan Gum (UNII: TTV12P4NEE) Levomenol (UNII: 24WE03BX2T) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Ethylhexylglycerin (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q) Ginger Oil (UNII: SAS9Z1SVUK) Sodium Hydroxide (UNII: 55X04QC32I) Green Tea Leaf (UNII: W2ZU1RY8B0) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 1,2-Hexanediol (UNII: TR046Y3K1G) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Benzoate (UNII: OJ245FE5EU) Chlorella Vulgaris (UNII: RYQ4R60M02) Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) Limonene, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-851-02 1 in 1 CARTON 11/12/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68479-851-01 1 in 1 CARTON 11/12/2021 2 12 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:68479-851-04 117 mL in 1 TUBE; Type 0: Not a Combination Product 11/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/12/2021 Labeler - Dermalogica, LLC. (177698560) Establishment Name Address ID/FEI Business Operations Cosway 052400223 MANUFACTURE(68479-851) Establishment Name Address ID/FEI Business Operations McKenna 090631412 MANUFACTURE(68479-851)
